Identity
- Trade Name
- VerifyNow™ System EUDAMEDVerifyNow System FDA UDI
- Generic Name
- Platelet aggregation analyser IVD FDA UDI
- Device Name
- VerifyNow™ System EUDAMEDVerifyNow System FDA UDI
- Model / Reference
- 86000 EUDAMEDFDA UDI
- Description
- VerifyNow System FDA UDI
Identifiers
- Catalog Number
- 86000 FDA UDI
- Primary DI / UDI-DI
- 10711234500040 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234500043LW EUDAMED
- 510(k) Number
- K992531 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- EMDN Code
- W0202010202 SEMI-AUTOMATED HEMATOLOGY ANALYSERS EUDAMED
- GMDN Term
- Platelet aggregation analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5700 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VerifyNow™ System by Accriva Diagnostics, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0711234500043LW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Accriva Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000009902
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4e81583c-b293-4cec-861d-03a492aac942 61 fields · synced Jul 10, 2026
- FDA UDI 979f74ed-6dd4-4884-bdf7-aadff324bba4 36 fields · synced May 25, 2026